Bioxodes SA, a clinical-stage biopharmaceutical company developing therapies for thrombotic and inflammatory diseases, has raised a €5.5 million Series A extension to continue preparations for a potentially registrational Phase 2b trial of BIOX-101 in intracerebral hemorrhage. The company said it plans to initiate the pivotal Phase 2b study in 2027 and believes the program could support BIOX-101 reaching the market as early as the second half of 2030.
Newton Biocapital joined the financing as a new investor, alongside other new and existing shareholders. Bioxodes said the extension brings total Series A financing to about €17.5 million and will support the work required to progress BIOX-101 into later-stage development.
The financing follows Bioxodes’ September update on interim results from its BIRCH Phase 2a trial in intracerebral hemorrhage. The company reported that the study met its safety endpoint and showed, it said, encouraging efficacy signals across clinical and biomarker measures. Bioxodes said the Data Monitoring Committee unanimously recommended launching a larger Phase 2b trial, a step the company is now planning around a 2027 start.
Bioxodes also outlined a regulatory and commercialization path tied to conditional approvals, stating that beginning the Phase 2b study in 2027 could allow submission for conditional marketing authorizations, with a go-to-market in the U.S. by late 2030 and in Europe by early 2031. Beyond intracerebral hemorrhage, the company said it also plans to develop BIOX-101 for ischemic stroke. To finance future clinical trials, Bioxodes said it has launched a €80 million Series B fundraising and is in active discussions with potential partners.
Intracerebral hemorrhage remains an area of significant unmet need, with no approved therapies, and Bioxodes framed BIOX-101 as a first-in-class candidate intended to address both clotting-related and inflammatory drivers of damage after hemorrhagic stroke. The company said intracerebral hemorrhage accounts for up to 40% of stroke-related deaths while representing about 15% of stroke cases, with mortality approaching 50% at 30 days, and about half of ICH-related deaths occurring within the first 24 hours. It also noted that fewer than 20% of survivors achieve functional independence after six months, often due to secondary damage linked to bleeding and inflammation.
Bioxodes described BIOX-101 as a proprietary recombinant version of a small protein found in the saliva of the tick Ixodes ricinus. The candidate is designed to reduce harmful secondary effects such as secondary ischemia, neuroinflammation, and neuronal damage. Unlike marketed anticoagulants that can exacerbate bleeding risk, the company said BIOX-101 has an anticoagulant effect shown not to increase bleeding by targeting Factors XIa and XIIa in the intrinsic coagulation pathway. It also described a second, anti-inflammatory mechanism through inhibition of neutrophil activation and their release of extracellular DNA filaments, also known as neutrophil extracellular traps, which can contribute to inflammation, edema expansion, and blood brain barrier disruption.
KEY QUOTES:
“Bioxodes is grateful for the renewed trust in the company’s ability to develop our groundbreaking treatment for hemorrhagic stroke. Our Phase 2a data clinical results in ICH patients are very promising and the principal investigator is encouraging us to push forward rapidly with registrational studies. I am particularly excited to see the respected specialist fund, Newton Biocapital, join our group of shareholders. The funding advances preparations for the pivotal Phase 2b trial and may enable us to bring BIOX-101 to patients as early as the second half of 2030,”
Marc Dechamps, CEO at Bioxodes
“Bioxodes looks to be a rare example of a success story in stroke. The BIOX-101 Phase 2a trial yielded very convincing data in intracerebral hemorrhage, an often deadly disease that presents an important unmet medical need. While the company is breaking new ground in this indication, we believe the path to registration is clear, with objective endpoints that look achievable based on the data at hand. BIOX-101 is exactly the kind of innovative drug that we at Newton like to have in our portfolio, also given our previous experience supporting companies in neurological and neurovascular diseases, including stroke,”
Alain Parthoens, Chief Executive Officer at Newton Biocapital
